FDA: Class I recall of Perseus A500 Anesthesia Workstation
Editor's Note The Food and Drug Administration, on December 23, 2015, classified the recall of the Perseus A500 Anesthesia Workstation by Draeger as Class I, the most serious. Draeger Medical (Telford, Pennsylvania) recalled the workstation because a faulty power switch may fail, causing the workstation to alarm and shut down…
FDA: Boston Scientific recalls Chariot Guiding Sheath
Editor's Note The Food and Drug Administration on December 11 announced that Boston Scientific (Marlborough, Massachusetts) recalled its Chariot Guiding Sheath because of the risk of shaft separation. The company received 14 complaints of shaft separation, four of which involved separation of the distal shaft. The Sheath is used to…
FDA: Class I recall of Inspiration LS, 5i, and 7i ventilators
Editor's Note The Food and Drug Administration on December 7 categorized the recall of Inspirtion LS, 5i, and 7i ventilator systems manufactured before January 21, 2015, by eVent Medical (Lake Forest, California) as Class I, the most serious. The recall was initiated because a faulty switch on the ventilators’ power…
FDA: Boston Scientific recalls RotaWire Elite and wireClip Torquer Guidewires
Editor's Note Boston Scientific Corporation is recalling RotaWire Elite core wires because they may crack and separate from the rest of the Rotablator Rotational Atherectomy System and cause serious injury such as tamponade, myocardial infarction, and migration of wire fragments, the Food and Drug Administration reported November 27. Boston Scientific…
FDA: Class I recall of G5 Ventilators by Hamilton
Editor's Note The Food and Drug Administration on November 13 identified the recall of Hamilton G5 Ventilators V2.00 and V2.31 as Class I, the most serious. The ventilator may stop working, without sounding an alarm, when the oxygen enrichment key is pressed to attach the mask to the patient. If…
FDA orders recall of all Custom Ultrasonics automated endoscope reprocessors
Editor's Note The Food and Drug Administration (FDA) on November 13 ordered Custom Ultrasonics (Ivyland, Pennsylvania) to recall all of its automated endoscope reprocessors from healthcare facilities because of federal law violations and a consent decree entered with the company in 2007. The violations could result in an increased risk…
GAO issues report on FDA postmarket studies on medical devices
Editor's Note More than half (56%) of 313 medical device postapproval studies ordered by the Food and Drug Administration (FDA) from January 1, 2007, through February 23, 2015, were for cardiovascular devices, and most are making adequate progress, according to a Government Accountability Office (GAO) report. Postapproval studies are ordered…
FDA: Quest Medical recalls certain lots of Myocardial Protection System delivery sets
Editor's Note Quest Medical, Inc (Allen, Texas), on October 28 initiated a nationwide recall of its Myocardial Protection System delivery sets, Models 5001102, 5001102-AS, and 7001102 of specified lots. The sets have shown possible seal failure along the blood source channel of the main pump cassette, resulting in blood loss…
FDA: Downing Labs recalls all sterile products
Editor's Note Downing Labs, LLC (Farmers Branch, Texas) is recalling all lots of compounded and packaged sterile products because of concerns of sterility assurance. The products were distributed between April 20 and September 15, 2015. Posted 10/21/2015] AUDIENCE: Consumer, Pharmacy ISSUE: Downing Labs, LLC is voluntarily recalling all lots…
FDA launches new features for UDI database
Editor's Note The Food and Drug Administration (FDA) in partnership with the National Library of Medicine on October 19 announced the launch of three new features on AccessGUDID, the public portal to data submitted to the FDA’s Global Unique Device Identification Database (GUDID). Two new APIs (application program interface) and…
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